Rezolute, Inc. has announced that the Phase 3 sunRIZE study results for ersodetug, a monoclonal antibody aimed at treating congenital hyperinsulinism (HI), will be presented at the upcoming Pediatric Endocrine Society Annual Meeting. The presentation, scheduled for May 1, 2026, will include both previously reported topline results and new data from pre-specified and post-hoc analyses, reinforcing the drug’s therapeutic efficacy and target engagement in patients who continue to experience hypoglycemia despite standard care.

The sunRIZE study was a multi-center, randomized, double-blind trial involving 63 participants aged 3 months to 45 years. It assessed the efficacy and safety of ersodetug compared to placebo, focusing on the reduction of hypoglycemia events and the average time spent in hypoglycemia over a six-month treatment period. Given that ersodetug operates downstream of the pancreas by allosterically binding to the insulin receptor, it presents a novel mechanism that could potentially address hypoglycemia across various forms of HI, including congenital and tumor-related cases.

The implications of these findings could significantly shift the landscape of treatment for hypoglycemia associated with HI. If confirmed, ersodetug could reduce the reliance on existing therapies and expedite the development of targeted treatments for patients with this rare disease. This study not only highlights the potential of ersodetug as a therapeutic option but also sets a precedent for future research into monoclonal antibodies targeting metabolic dysregulation in aging and related conditions.

Source: globenewswire.com